- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02545725
Quality of Life in Colorectal (ex-)Cancer Patients, Based on the Belgian Cancer Registry. (QOLColorect)
Quality of Life in (ex-)Cancer Patients, Based on the Belgian Cancer Registry. Pilot Study: Quality of Life in Colorectal (ex-)Cancer Patients.
This study is collecting data on quality of life, (care)needs and socio-economic factors in colorectal (ex-)cancer patients via a written questionnaire completed by the patient him/herself. The collected data will be linked with the patient- and tumour characteristics available in the database of the Belgian Cancer Registry and with the facturation data supplying information about diagnostic techniques and performed treatments (available via the insurance companies).
Based on the selection criteria, 1220 patients were finally selected from the database of the Belgian Cancer Registry. These patients received an invitation letter by regular mail, a detailed questionnaire and an informed consent.
The questionnaire contains topics as sociodemographic, life style, comorbidity, satisfaction with the provided information, care needs, quality of life, anxiety and depression, financial situation etc.
The patients were asked to complete the questionnaire and send it back, together with the signed informed consent, to the study-collaborators.
After 2-4 weeks, a reminder was sent. At that time, a reply card was added. If a patient doesn't want to participate in this study, a reason can be mentioned on the reply card.
The collected data are linked with the clinical data. The dataset will be coded before analyses will start.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Koningsstraat 215 b7
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Brussels, Koningsstraat 215 b7, Bélgica, 1210
- Belgian Cancer Registry
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients of colorectal cancer (ICD-10: C18-C19-C20) with incidence in 2008-2010 were selected for this study. Patients are at least 18 years old at diagnosis and maximal 90 years old when completing the questionnaire.
Patients are living in Flanders, speak Dutch and are followed in 1 of the 7 participating hospitals.
The patients are able to complete the questionnaire themselves: patients with cognitive problems are excluded.
Descrição
Inclusion Criteria:
- Invasive colorectal cancer (ICD-10: C18-C19-C20)
- Patient knows his/her diagnosis of cancer
- Incidence in 2008, 2009 or 2010
- The patient is at least 18 years at diagnosis
- The patient is maximal 90 years when completing the questionnaire
- The patient lives in Flanders and speaks Dutch
- The patient is treated/followed by 1 of the 7 participating hospitals
- The patient is able to complete the questionnaire him/herself (no cognitive problems)
Exclusion Criteria:
- More than 1 invasive tumour diagnosed
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Questionnaire on Quality of Life
Prazo: 5-8 years after diagnosis
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5-8 years after diagnosis
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Questionnaire on Quality of Life
Prazo: At the moment of diagnosis and primary treatment (until +/- 1 year after diagnosis)
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At the moment of diagnosis and primary treatment (until +/- 1 year after diagnosis)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Elizabeth Van Eycken, Director Belgian Cancer Registry
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- S57073
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